Question 1

“Allowing insufficient time, equipment and/or training for developing the audit programme or conducting an audit” is a risk associated with ____________.

Options :

A : Resources

B : Communication

C : Planning

D : Control of documented information

Answer: A

Question 2

Which of the following control charts is used to trend continuous data?

Options :

A : X-bar chart

B : U chart

C : np chart

D : P chart

Answer: A

Question 3

Employees working in the controlled environment should be properly trained on ___________.

Options :

A : Gowning procedures

B : Requirements for attire and behavior

C : Gowning procedures, requirements for attire and behavior

D : Gowning procedures and requirements for attire

Answer: C

Question 4

Which of the following is to identify high-risk manufacturing or product-usage steps that could lead to potential harms?

Options :

A : Control chart

B : Scatter diagram

C : Brainstorming

D : Flowchart

Answer: D

Question 5

According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.

Options :

A : Device label and package

B : Device package

C : Device itself as a permanent UDI

D : Device label

Answer: A